701 East Washington StreetTampa FL 33602

ALLEY u CLARK u GREIWE 701 E WASHINGTON STREET TAMPA FL 33602 TEL (813) 222-0977 FAX (813) 224-0373 TOLL FREE (800) 840-0977

C l i e n t n e w s l e t t e r s u m m e r 2 0 1 3

ALLEY u CLARK u GREIWE 701 E WASHINGTON STREET TAMPA FL 33602 TEL (813) 222-0977 FAX (813) 224-0373 TOLL FREE (800) 840-0977

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PAIDTAMPA FL

PERMIT NO 3024

In BrIef

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AlleyClarkGreiwe

FDA IssuesWarning On

Popular BloodPressure

Medication

Health Care Liens- What You Need To

Know

Social MediaPrivacy

Zofran Claims

FDA ISSUES WARNING ON POPULARBLOOD PRESSURE MEDICATION

S U M M E R 2 0 1 5

In This Edition

bull Nearly all personal health care policies contain reimbursement languagebull Paying premiums and co-pays does NOT negate or have any effect on reimbursing an insurer

bull Attorneys are bound by state and federal law to notify insurers of a pending lawsuitbull Failure to reimburse an insurer can result in fines penalties and loss of coverage for the insured

Medical Malpractice Unsafe Drugs Automobile Accidents

Products Liability Defective Medical Devices Wrongful Death

Representing Plaintiffs Exclusively in the Following Cases

Benicar was approved for sale in the US in 2002 to control hypertension (high blood pressure) In July of 2013 the FDA issued a Drug Safety Communication warning the public that ingestion of Benicar could cause intest inal problems known as sprue-like enteropathy Symptoms of this condition include severe chronic diarrhea with substantial weight loss The enteropathy may develop months to years after starting Benicar and sometimes requires hospitalization The connection between sprue-like enteropathy and Benicar was first reported by Mayo

Clinic researchers in June 2012 In the Mayo research all of the patients had used Benicar for at least a year before developing symptoms

Alley Clark amp Greiwe continues to litigate a number of pharmaceutical drugs cases Each personal injury attorney at our law firm has extensive experience representing

clients seriously injured due to defective medical devices and drug products If you or someone you know has developed serious GI problems after taking Benicar please contact Alley Clark amp Greiwe for a free consultation regarding your legal rights

HEALTH CARE LIENS - WHAT YOU NEED TO KNOWIf you sustain personal injuries as a result of a third party and you later file a lawsuit your health insurer must be reimbursed for medical expenses it paid for injuries that form the basis of your lawsuit These are commonly referred to as health care ldquoliensrdquo Whether you are insured by a private health care plan (ie Blue Cross Cigna Aetna etc) an employee benefit plan or a

government health program (ie Medicare Medicaid Tricare) your health insurer has a legal right to reimbursement from your settlement proceeds The resolution of these health insurance liens can be a long frustrating process In most cases health care liens can be negotiated andor reduced unless the insurance policy language specifically requires 100 reimbursement

Important Information About Your Health Insurance Reimbursement Obligations

In BrIefIn BrIefC l i e n t n e w s l e t t e r s u m m e r 2 0 1 3

In BrIefIn BrIefw w w t a m p a t r i a l l a w y e r s c o m s u m m e r 2 0 1 3

ALLEY u CLARK u GREIWE 701 E WASHINGTON STREET TAMPA FL 33602 TEL (813) 222-0977 FAX (813) 224-0373 TOLL FREE (800) 840-0977ALLEY u CLARK u GREIWE 701 E WASHINGTON STREET TAMPA FL 33602 TEL (813) 222-0977 FAX (813) 224-0373 TOLL FREE (800) 840-0977

Zofran claimshot topicsS U M M E R 2 0 1 5 S U M M E R 2 0 1 5

Timeline of Zofran Birth Defects Research To DateAuto Accidents

Car truck motorcycle bicycleand pedestrian accidents

accidentsinjuries caused by distracted drivers

Medical MalpracticeSerious permanent injuries

caused by error ofa medical provider

Wrongful DeathAccidental death caused bythe action of another (drugcompany reckless driver

medical mistake)

Vaginal MeshSynthetic mesh used in femalesto correct pelvic organ prolapse

andor urinary incontinence

XareltoAn alternative to Coumadinthis blood thinner has beenlinked to serious bleeding

events and fatalities

Metal-on-Metal HipsHip implants linked to high

failure rates metallosispseudo-tumors chronic pain

Testosterone ReplacementTestosterone supplementslinked to increased risk of

stroke heart attack and death

BenicarBlood pressure medication

linked to seriousgastrointestinal complications

ZofranNausea medication prescribed

during pregnancy linked toserious birth defects

Off-label use of zofran during pregnancy Everything you post on the internet is public These days almost everyone is on social networking websites liked LinkedIn Instagram or Facebook Despite passwords and privacy settings you should expect that your pictures posts or status updates will be discoverable should you file a personal injury lawsuit This is confirmed by case law throughout the State of Florida and more recently in the case of Nucci v Target Corp 2015 WL 71726 (Fla 4th Dist App Jan 7 2015) In this case the Plaintiff slipped and fell in a Florida Target store and later sued the retail giant and its cleaning company for back neck and shoulder injuries The Plaintiff was ordered to produce ldquoscreen shotsrdquo and photos she posted on Facebook for the two year period before her accident The Plaintiff argued that her Facebook account had a privacy setting The Court however noted that in

Florida the scope of discovery in civil cases is broad and that her photos were highly relevant to her personal injury claim Essentially the Court felt the Plaintiffrsquos Facebook page would demonstrate her activities both before and after her slip and fall accident

Postings on social media websites are likely to become akin to surveillance videos and this issue will continue to impact personal injury and medical malpractice cases alike

Zofran is a medication approved to treat nausea and vomiting during chemotherapy or following major surgery This powerful anti-nausea drug has been prescribed extensively ldquooff-labelrdquo by physicians to women to treat nausea during pregnancy However Zofran is not approved to treat pregnant women and there are studies which suggest a link between the drug and serious birth defects The manufacturer has never conducted a large scale study regarding the safety of Zofran when prescribed to expectant mothers While drug manufacturers and their sales representatives are not legally allowed to promote off-label uses for prescribed medications there is no law or regulation preventing doctors from this practice

GlaxoSmithKline the manufacturer of Zofran was sued in 2011 by the US Department of Justice for off-label drug promotion for several prescription

drugs including Zofran The civil lawsuit alleged GSK illugally promoted certain prescription drugs it failed to report certain safety data it paid kickbacks to medical providers to promote and prescribe certain drugs and it alleged false price reporting practices Simultaneous criminal charges were also filed by the DOJ against GSK relating to the drugs Paxil Wellbutrin and Avandia In 2012 GSK pled guilty to the criminal charges and also agreed to pay the US Government a total penalty of $3 billion to resolve the civil and criminal liability This is the largest health care fraud settlement in US history and the largest payment ever by a drug company

If you or someone you know was prescribed Zofran during pregnancy and later delivered a child with serious birth defects please contact Alley Clark amp Greiwe for a free consultation regarding your legal rights

2004

2012

Feb 2013

Aug 2013

Motherisk in Canada published an observational study of 200 mothers which found no link between Zofran and birth defects They study was supported by an unrestricted grant from GlaxoSmithKline (manufacturer of Zofran)

A study published by the Center for Birth Defects Research amp Prevention and conducted by Slone Epidemiology (Boston) and the Centers for Disease Control and Prevention (Atlanta) examined select anti-nausea drugs and birth defect rates finding that first trimester exposure to Zofran resulted in an increased rate of cleft palate

The New England Journal of Medicine published a study based on select Danish birth records dating from 2004-2011 This study did not detect a link between Zofran and birth defects Critics of this study state the sample size was too small and included many women who did not start taking Zofran until after Week 10 of their pregnancy when a fetus is no longer at risk for developing major birth defects

Another group of researchers published a study on Zofran birth defects based on the same Danish birth records data expanding their scope to examine records ranging from 1997-2010 This study which is by far the most comprehensive study on Zofran birth defects found the drug doubles the risk of congenital heart defects and increases the risk of birth defects overall by 30 The sample group included 1248 women who took Zofran during their first trimester of pregnancy

CURRENT LITIGATION PROJECTS

In BrIefIn BrIefC l i e n t n e w s l e t t e r s u m m e r 2 0 1 3

In BrIefIn BrIefw w w t a m p a t r i a l l a w y e r s c o m s u m m e r 2 0 1 3

ALLEY u CLARK u GREIWE 701 E WASHINGTON STREET TAMPA FL 33602 TEL (813) 222-0977 FAX (813) 224-0373 TOLL FREE (800) 840-0977ALLEY u CLARK u GREIWE 701 E WASHINGTON STREET TAMPA FL 33602 TEL (813) 222-0977 FAX (813) 224-0373 TOLL FREE (800) 840-0977

Zofran claimshot topicsS U M M E R 2 0 1 5 S U M M E R 2 0 1 5

Timeline of Zofran Birth Defects Research To DateAuto Accidents

Car truck motorcycle bicycleand pedestrian accidents

accidentsinjuries caused by distracted drivers

Medical MalpracticeSerious permanent injuries

caused by error ofa medical provider

Wrongful DeathAccidental death caused bythe action of another (drugcompany reckless driver

medical mistake)

Vaginal MeshSynthetic mesh used in femalesto correct pelvic organ prolapse

andor urinary incontinence

XareltoAn alternative to Coumadinthis blood thinner has beenlinked to serious bleeding

events and fatalities

Metal-on-Metal HipsHip implants linked to high

failure rates metallosispseudo-tumors chronic pain

Testosterone ReplacementTestosterone supplementslinked to increased risk of

stroke heart attack and death

BenicarBlood pressure medication

linked to seriousgastrointestinal complications

ZofranNausea medication prescribed

during pregnancy linked toserious birth defects

Off-label use of zofran during pregnancy Everything you post on the internet is public These days almost everyone is on social networking websites liked LinkedIn Instagram or Facebook Despite passwords and privacy settings you should expect that your pictures posts or status updates will be discoverable should you file a personal injury lawsuit This is confirmed by case law throughout the State of Florida and more recently in the case of Nucci v Target Corp 2015 WL 71726 (Fla 4th Dist App Jan 7 2015) In this case the Plaintiff slipped and fell in a Florida Target store and later sued the retail giant and its cleaning company for back neck and shoulder injuries The Plaintiff was ordered to produce ldquoscreen shotsrdquo and photos she posted on Facebook for the two year period before her accident The Plaintiff argued that her Facebook account had a privacy setting The Court however noted that in

Florida the scope of discovery in civil cases is broad and that her photos were highly relevant to her personal injury claim Essentially the Court felt the Plaintiffrsquos Facebook page would demonstrate her activities both before and after her slip and fall accident

Postings on social media websites are likely to become akin to surveillance videos and this issue will continue to impact personal injury and medical malpractice cases alike

Zofran is a medication approved to treat nausea and vomiting during chemotherapy or following major surgery This powerful anti-nausea drug has been prescribed extensively ldquooff-labelrdquo by physicians to women to treat nausea during pregnancy However Zofran is not approved to treat pregnant women and there are studies which suggest a link between the drug and serious birth defects The manufacturer has never conducted a large scale study regarding the safety of Zofran when prescribed to expectant mothers While drug manufacturers and their sales representatives are not legally allowed to promote off-label uses for prescribed medications there is no law or regulation preventing doctors from this practice

GlaxoSmithKline the manufacturer of Zofran was sued in 2011 by the US Department of Justice for off-label drug promotion for several prescription

drugs including Zofran The civil lawsuit alleged GSK illugally promoted certain prescription drugs it failed to report certain safety data it paid kickbacks to medical providers to promote and prescribe certain drugs and it alleged false price reporting practices Simultaneous criminal charges were also filed by the DOJ against GSK relating to the drugs Paxil Wellbutrin and Avandia In 2012 GSK pled guilty to the criminal charges and also agreed to pay the US Government a total penalty of $3 billion to resolve the civil and criminal liability This is the largest health care fraud settlement in US history and the largest payment ever by a drug company

If you or someone you know was prescribed Zofran during pregnancy and later delivered a child with serious birth defects please contact Alley Clark amp Greiwe for a free consultation regarding your legal rights

2004

2012

Feb 2013

Aug 2013

Motherisk in Canada published an observational study of 200 mothers which found no link between Zofran and birth defects They study was supported by an unrestricted grant from GlaxoSmithKline (manufacturer of Zofran)

A study published by the Center for Birth Defects Research amp Prevention and conducted by Slone Epidemiology (Boston) and the Centers for Disease Control and Prevention (Atlanta) examined select anti-nausea drugs and birth defect rates finding that first trimester exposure to Zofran resulted in an increased rate of cleft palate

The New England Journal of Medicine published a study based on select Danish birth records dating from 2004-2011 This study did not detect a link between Zofran and birth defects Critics of this study state the sample size was too small and included many women who did not start taking Zofran until after Week 10 of their pregnancy when a fetus is no longer at risk for developing major birth defects

Another group of researchers published a study on Zofran birth defects based on the same Danish birth records data expanding their scope to examine records ranging from 1997-2010 This study which is by far the most comprehensive study on Zofran birth defects found the drug doubles the risk of congenital heart defects and increases the risk of birth defects overall by 30 The sample group included 1248 women who took Zofran during their first trimester of pregnancy

CURRENT LITIGATION PROJECTS